Acthar Gel is approved by the
The primary efficacy endpoint of the study was the proportion of patients who improved by 12 points or more in the symptom bother module of the Impact of Dry Eye on Everyday Life (IDEEL) score at week 12. The IDEEL is a patient-reported outcome assessment with three modules—impact on daily life, treatment satisfaction and symptom bother—and six dimensions. After 12 weeks of treatment with Acthar Gel, 50.0 percent (n=17) of patients experienced improvements in their symptom bother score by at least 12 points, a clinically important change3 (95% CI 33.2, 66.8).4
"As ophthalmologists, we rely heavily on patient-reported symptoms when evaluating severe keratitis, especially for those who require alternative treatments," said one of the study authors
Exploratory endpoints included the change from baseline to week 12 in each item of the Visual Analog Scale (VAS), and corneal fluorescein staining and conjunctival lissamine green staining as measured by Ora Calibra™ scales. After 12 weeks of treatment with Acthar Gel, all symptoms assessed by the VAS had improved from baseline, with the most pronounced improvements observed for eye dryness and discomfort. Additionally, improvements from baseline in corneal fluorescein staining and conjunctival lissamine green staining were observed as early as week four and were sustained through week 12. Additionally, the proportions of patients who experienced greater than or equal to 20, 30 or 50 percent improvement in the IDEEL symptom bother score at week 12 were 50.0 percent (95% CI 33.2, 66.8), 44.1 percent (95% CI 27.4, 60.8) and 14.7 percent (95% CI 2.8, 26.6), respectively.4
Safety was assessed regarding treatment-emergent adverse events (TEAEs) and serious TEAEs collected throughout the study. Of patients in the safety population (n=36), 33.3 percent experienced ≥1 TEAE after initiation of Acthar Gel treatment; most TEAEs were single incidences. In the study, the most commonly reported TEAE was hypertension (n=2). No serious TEAEs were related to the study drug.4
"These data provide meaningful evidence to support Acthar Gel's potential role in improving outcomes for patients with severe keratitis that persists after the use of one or more standard treatments," said
About the Study4:
About Severe Keratitis
Keratitis is a painful inflammation of the cornea and is a significant cause of ocular morbidity around the world.1 It can result from infectious agents (e.g., microbes including bacteria, fungi, amebae and viruses) or from noninfectious causes (e.g., eye trauma, chemical exposure and ultraviolet exposure).5 Non-infectious severe keratitis may be associated with various collagen vascular or other autoimmune diseases, sometimes as the presenting sign of the disease.6
IMPORTANT SAFETY INFORMATION
Acthar is contraindicated:
Warnings and Precautions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information for additional Important Safety Information.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
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Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2021 Mallinckrodt. US-2001768 04/21
1 Sharma S. Keratitis. Bioscience Reports. 2001;21:419-444.
2 Acthar® Gel (repository corticotropin injection) [prescribing information].
3 Fairchild CJ, et al. Optom
4 Grieco J, McLaurin E, Ousler G, Liu J, Kacmaz O, Wirta D. Results from a multicenter, open-label, Phase 4 study of repository corticotropin injection in patients with treatment-resistant severe non-infectious keratitis. Presented at:
5 Collier SA, Gronostaj MP, MacGurn, AK, Cope JR, Awsumb KL, Yoder JS, et al. Estimated burden of keratitis--
6 Donzis PB, Mondino BJ. Management of noninfectious corneal ulcers. Surv Ophthalmol. 1987;32:94–110.
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